Completed

NCT Number: NCT00467441

VSF-173 Study in Healthy Adult Volunteers for Treatment of Induced Excessive Sleepiness

The purpose of this study is to determine the safety and efficacy of VSF-173 compared to placebo in treatment of induced excessive sleepiness.

Completed

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Key information

Conditions

Excessive Somnolence

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vanda Investigational Site

Dijon, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy subjects with no medical, psychiatric, or current sleep disorders
Subject must sign a written consent form

Exclusion criteria

Evidence of excessive daytime sleepiness
History of sleep disorders
Psychiatric or neurological disorders

Treatment and study plan

VSF-173

Drug

Primary outcomes

Ability to stay awake as assessed by Maintenance of Wakefulness Test (MWT)

Secondary outcomes

Mood
Psychomotor performance
Safety and tolerability

Sponsors and collaborators

Lead sponsor

Vanda Pharmaceuticals

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Investigate the Efficacy and Safety of VSF-173 and Matching Placebo in Healthy Male and Female Subjects With Induced Excessive Sleepiness

Important dates

First posted: Apr 30, 2007
Registry last updated: Nov 2, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.